UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011622 |
|---|---|
| Receipt number | R000013575 |
| Scientific Title | Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2021/03/09 17:03:32 |
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Basic information
Public title
Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Acronym
Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Scientific Title
Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Scientific Title:Acronym
Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Region
| Japan |
Condition
Condition
vitiligo vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To calculate depigmented ratio and evaluate effectiveness of the treatment after smash grafting therapy for vitiligo vulgaris
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effectiveness by calculating depigmented ratio at 3 and 6 months after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Obtain shaved skin from donor sites, cut into small pieces by scissors and apply to the dermabraded recipient sites.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Vitiligo vulgaris patient whose lesion has not changed for at least a year.
2. Disease type: diffuse, localized, segmented.
3. Patient with written informed consent for the treatment.
Key exclusion criteria
1. Vitiligo vulgaris patient whose lesion is progressing.
2. Patient with severe systemic disease.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuya Aiba |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Dermatology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL
022-717-7271
saiba@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Kimura |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Dermatology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL
022-717-7271
Homepage URL
yutakakimura@m.tohoku.ac.jp
Sponsor or person
Institute
Department of Dermatology
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013575
